Kornimate/medical-research-clean huggingface dataset:
prospective surveillance for very early hepatocellular carcinoma

Conditions: Carcinoma, Hepatocellular

Summary: hepatocellular carcinoma is one the leading cause of increasing cancer-specific mortality worldwide. early diagnosis of hepatocellular carcinoma provides opportunity for curative therapeutic approaches and relatively favorable prognosis. herein, we intended to establish a biosignature for early diagnosis of hepatocellular carcinoma and stratification of risk population for intensive follow-up by implementing biannual follow-up investigation and collecting peripheral blood samples for screening.

patients will be recruited for 1 year and be follow-up for 3 years. patients will make active hospital visit for collection of blood samples, which will be analyzed to develop a biosignature at the end of the study to detect very early hepatocellular carcinoma and stratify risk population for intensive follow-up.

Eligibility criteria:
inclusion criteria: - \[1\] cirrhosis cohort 1. age within 30 to 75 years. 2. diagnosis of liver cirrhosis within recent 6 months. 1. liver biopsy: metavir score of 4 or ishak score of 5 to 6. 2. no liver biopsy: presence of ascites, hepatic encephalopathy, or variceal hemorrhage. 3. satisfying equal to or more than 2 of below conditions. * imaging studies indicating characteristics of liver cirrhosis: irregular liver surface, liver parenchyma particles or nodules, intraperitoneal collateral circulation, or varicose veins with or without splenomegaly (more than 4 cm or 5 ribs). * platelet count \< 200 x 10\^9/l. * alanine aminotransferase \ 12 kpa. * gastroesophageal varices from endoscopy or imaging studies. \[2\] hbv infection cohort 1. age within 40 to 70 years 2. chronic hbv infection (seropositive for hbsag over 6 months). exclusion criteria: 1. cirrhosis cohort (1) child-pugh score of c. (2) hereditary metabolic liver diseases. (3) presence of hiv-ab. (4) previous diagnosis of active pulmonary tuberculosis. (5) diagnosis of malignant tumors before or during hospitalization, including but not limited to hepatocellular carcinoma. (6) patients who had received allogeneic blood transfusion or cell therapy within 1 year. (7) pregnant women. \[2\] hbv infection cohort (1) autoimmune liver diseases. (2) hereditary metabolic liver diseases. (3) other chronic liver diseases, such as flukes. (4) presence of hcv, hdv, hev, or hiv infection. (5) previous diagnosis of active pulmonary tuberculosis. (6) diagnosis of malignant tumors before or during hospitalization, including but not limited to hepatocellular carcinoma. (7) patients who had received allogeneic blood transfusion or cell therapy within 1 year. (8) pregnant women.
mertk signalling in monocytes/macrophages in patients with liver disease

Conditions: Liver Disease; Cirrhosis of the Liver; Acute-On-Chronic Liver Failure; Liver Failure

Summary: this study is to investigate mer receptor tyrosine kinase (mertk) signalling cascade on monocytes and tissue macrophages in respect to innate immune function of the cells in patients with cirrhosis at different stages of disease (child a, b, c, acute decompensation, acute-on-chronic liver failure (aclf)) and in comparison to patients with acute liver failure and to healthy controls.

mer receptor tyrosine kinase (mertk) signalling cascade becomes activated on monocytes/macrophages during disease progression of liver cirrhosis from child pugh a to b/c, corresponding to early stages of decompensation, and before the receptor expression is increased. factors involved in activation of the mertk signalling cascade might be microbial products such as bacterial deoxyribonucleic acid (dna) and other toll-like receptor (tlr)-ligands, mertk ligands and cytokines, as shown elevated in cirrhotic patients. given the observation that mertk levels peak on the day of admission with organ failure and decrease in patients surviving the episode of acute-on-chronic liver failure (aclf), mertk inhibition at a time during progression of cirrhosis but before manifestation of acute decompensation with no cirrhosis (ad) or aclf might prevent infectious complications, decompensation and improve survival in patients with cirrhosis. this study is to investigate mer receptor tyrosine kinase (mertk) signalling cascade on monocytes and tissue macrophages in respect to innate immune function of the cells in patients with cirrhosis at different stages of disease (child a, b, c, acute decompensation, acute-on-chronic liver failure (aclf)) and in comparison to patients with acute liver failure and to healthy controls.

Eligibility criteria:
inclusion criteria: * patients with compensated or decompensated chronic liver disease * patients with acute- or acute-on-chronic chronic liver failure * controls with no liver disease exclusion criteria: * evidence of disseminated malignancy

Keywords: immunoparesis monocyte dysfunction mer receptor tyrosine kinase (mertk) innate immune dysfunction circulating monocytes/macrophages mertk signalling
a prospective trial of coxen chemotherapy prediction

Conditions: Ovarian Neoplasms; Fallopian Tube Neoplasms

Summary: the purpose of this study is to determine if the coxen algorithm, using the diagnostic device affymetrix genechip, is able to predict which chemotherapies will be best for treatment of recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer.

the current proposal seeks to apply and extend this novel genomic prediction technique to finding better chemotherapeutic options for recurrent ovarian cancer using individual patients' gene-expression signatures of chemosensitivity. the utility of the coxen technique has been validated and found to accurately predict 1) the chemosensitivity of an independent panel of 40 bladder cancer cell lines; 2) activity of each of the \>45k candidate compounds in the nci-60 drug screening database, which resulted in the identification of a highly-effective novel compound for bladder cancer and patients' responses and survival on 12 historical clinical trials of combination chemotherapy. in particular, the gems of breast cancer can be used to stratify both clinical response and overall patient survival with a striking difference between the predicted responders vs. predicted non-responders in 5 independent chemotherapeutic trials of breast cancer. the next step is to test the prediction model in recurrent ovarian cancer.

Eligibility criteria:
inclusion criteria: * age greater than 18 * diagnosis of recurrent, persistent, refractory ovarian, fallopian or primary peritoneal cancer * tumor tissue, ascites or pleural fluid available for biopsy * life expectancy greater than 6 months exclusion criteria: * patients with borderline or low malignant histologies * patients with a history of other malignancies within last 5 years

Keywords: ovarian cancer fallopian tube cancer primary peritoneal cancer
study of low-level laser therapy in the acute treatment of migraine

Conditions: Migraine Headache

Summary: this study evaluates the treatment of migraine pain using low energy laser light to quench migraine signals issuing from the sphenopalatine ganglion (spg).

this is a double blinded, two arm study, comprising a sham laser and a treatment laser. the sham laser emits approximately 1/1000 the energy of the treatment laser. it is presumed that pain relief from the treatment laser is achieved by exhausting the release of neurotransmitters from the spg following laser stimulation. subjects will be treated and subsequently queried at time intervals for their self-assessment of pain score (vas). the time intervals include queries at 5 minutes through 2 hours post treatment. subjects will be further contacted 24 hours and one month post treatment. adverse events will be monitored and recorded.

Eligibility criteria:
inclusion criteria * male or female * aged 18 or older; * subject diagnosed with migraine according to the international classification of headache disorders- version 3; * 1-20 headache days per month; * history of at least moderate pain if migraine left untreated. exclusion criteria: * headache on greater than 25 days/month on average for preceding 3 months; * headache on greater than 25 days in present month; * headache attributed to: head or neck trauma, cluster headache, specific migraine variants such as basilar artery, ophthalmoplegic, hemiplegic, etc; * women of child bearing age not using acceptable method of contraception; * pregnant or nursing women; * history of malignancy of any organ * uncontrolled: hypertension, severe psychiatric disorders, or known use of narcotics, analgesic or alcohol abuse; * light sensitivity; * retinal disease; * intranasal pathology.
probiotics as adjuvant therapy in the treatment of metastatic colorectal cancer

Conditions: Colorectal Cancer Metastatic

Summary: the research will be prospective, randomised, placebo controlled and double-blinded.the research will be carried on with regards to helsinki declaration and following the guidelines of good clinical practice.

the investigators plan this research to be prospective, randomized, placebo-controlled and double blinded. it will be held according to declaration of helsinki and in harmony with good clinical practice guidelines. all patients would be required to sign informed consent, approved by the ethics committee of clinical hospital center (chc) rijeka. all patients will have at their disposal current medications for diarrhea based on guidelines, and education regarding side effects and dietary recommendations will be undertaken. one cohort will also ingest a probiotic (omni-biotic® 10aad), while other cohort will take a placebo, same in colour, shape, taste and smell; both medications will be taken 2 per day, every 12 hours, over 84 days (6 chemotherapy cycles every 14 days). after 84 days, a regular examination will be undertaken. total follow-up would be for two full cycles, at least 160 days. (stool analyses will take place before and after chemotherapy(6-8 weeks after chemotherapy) and eventually three month later) patients will be followed up in six main control points, t1, t2, t3, t4, t5, t6, which all represent the 1st day of matching 2-week-chemotherapy cycle. each cycle starts exactly and at least 14 days from the first day of previous chemotherapy cycle. there would be no additional invasive procedures done for this study, regular blood examinations will be expanded with additional parameters. all patients would have the right to withdraw their written consent to participate in the study at any given time and for any reason whatsoever. (fecal analyses only before and 6-8 weeks after the last chemotherapy cycle)

Eligibility criteria:
inclusion criteria: * a histologically confirmed diagnosis of colorectal cancer with metastasis; * patients older than 18 years of age; * patients starting first line of chemotherapy (folfiri protocol); * signed patient consent form. exclusion criteria: * present ileostomy; * decompensated patients; * terminal stage patients (\<6 months life expectancy); * patients not mentally able to adhere to the protocol; * patients using \>3 yoghurts per week or any other probiotics; * or any other condition which would not allow safe administration of the drugs.
low dose methoxyflurane for pain relief during minor out-patient urologic procedures

Conditions: Pain, Acute

Summary: the participant will be trained to self administer the drug and will be supplied with a penthrox commercial inhaler kit .the study nurse will train the participant and supervise its use during the procedure.immediately following the procedure the participant will be asked to fill out two brief questionnaires. the study nurse will assess the participant for adverse event and will follow-up with a phone call 24 hours later.

many patients with chronic urological conditions require multiple and sometimes painful urological procedures. ideally these procedures may be done in the cystoscopy suite without a general anesthetic. low dose methoxyflurane, (meof)is a inhaled, self-administered non-opioid analgesic and has been approved by health canada's for the short-term relief of moderate to severe acute pain, associated with trauma or international medical procedures, in conscious adult patients. the brand name is penthrox. this study is a single centre, pilot study to assess the feasibility of using a self-administrated, meof for pain relief during minor out-patient urological procedures. eligible participants will receive a one time dose of the the study medication during a planned, outpatient urological procedure done under cystoscopy in the cystoscopy clinic

Eligibility criteria:
inclusion criteria: 1. conscious adult patients \>= 2. patient is scheduled for cystoscopy and: * botox injections for overactive bladder /neuogenic detrusor overactivity, * diagnostic hydrodistention for painful bladder syndrome * biopsy or cauterization of bladder tumors * biopsy, cauterization and/or injection of hunner's lesions * visual urethrotomy/bladder neck incision=/- injection of stricture * evaluation of the complex urinary tract problems 3. patient (patient/or patient's authorization legal representative) should understand the nature of the study and provide written informed consent 4. patient is able to follow all study requirements and procedures and complete required questionnaires exclusion criteria: 1. an altered level of consciousness, due to any cause, including head injury, drugs,or alcohol 2. clinically significant renal impairment 3. women of child bearing potential who are pregnant or peri partum, including labour 4. a history of liver dysfunction after previous meof use or other halogenated anesthetics 5. hypersensitivity to meof or other halogenated anesthetics, or to butylated hydroxytoluene 6. known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives 7. exacerbation of an underlying condition (i.e., chronic pain) 8. clinically evident or potential hemodynamic instability as per the opinion of the investigator 9. clinically evident respiratory impairment as per the opinion of the investigator 10. prior treatment with penthrox within 3 months
a first human dose trial investigating safety, tolerability and pharmacokinetics for single doses of nnc9204-1177 in subjects being overweight or with obesity.

Conditions: Metabolism and Nutrition Disorder; Obesity

Summary: trial investigating safety, tolerability and pharmacokinetics for single doses of nnc9204-1177 in subjects being overweight or with obesity


Eligibility criteria:
inclusion criteria: * male, aged 18-55 years (both inclusive) at the time of signing informed consent * body mass index (bmi) between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening exclusion criteria: * any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol * subjects, aged at least 40 years, with an estimated 10-year atherosclerotic cardiovascular disease (ascvd) (as described in the american college of cardiology and the american heart association prevention guideline) risk above or equal to 5% * male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) who are not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (pearl index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product
gpur- luminating oral cholesterol kinetics pilot study

Conditions: Cholesterol Absorption

Summary: in healthy subjects not receiving or requiring lipid lowering therapy and who do not have diabetes, the use of clinoptilolite (gpur) will result in a reduction of absorbed dietary cholesterol observed over 6 days of therapy.


Eligibility criteria:
inclusion criteria: * adults over 18 years of age * not receiving or requiring lipid lowering therapy * willingness to give informed consent * able to keep a dietary log * willing to maintain a consistent day to day routine during the study (no major changes in lifestyle, exercise, food pattern, smoking habits, etc) exclusion criteria: * current use of oral lipid binding agents (colesevelam, cholestyramine, ezetimibe) fibrates, niacin or statins * current use of dietary supplements enriched with fat soluble vitamins, mono/polyunsaturated fat (fish-oil etc.) or probiotics * any oral antibiotic use, currently or within the past 14 days * diabetes, type i and type ii * currently following a restrictive diet * gi motility disorders (irritable bowel syndrome, diabetic gastroparesis, etc) * prior gastric or bowel resection * inflammatory bowel disease (crohns, ulcerative colitis, diverticulitis, celiac sprue, etc) * co-morbidities with anticipated life expectancy \< 12 months * esrd on dialysis * known intolerance to silicium or aluminum compounds * excess alcohol consumption (\>1 drink per day) * pregnancy, nursing or not taking/using contraception * hepatobiliary disorders or renal disease * plasma total cholesterol \> 240mg/dl or triglycerides \> 265.5 mg/dl * no plant-sterol enriched food products allowed in diet \& supplements * bmi \> 35
comparing efficacy and safety of thrice daily versus twice daily novomix® 30 (biphasic insulin aspart 30) in subjects with type 2 diabetes inadequately controlled with basal insulin

Conditions: Diabetes; Type 2 Diabetes Mellitus

Summary: this trial is conducted in asia. the aim of the trial is to compare efficacy and safety of thrice daily versus twice daily novomix® 30 (biphasic insulin aspart 30) in subjects with type 2 diabetes inadequately controlled with basal insulin.


Eligibility criteria:
inclusion criteria: * male or female, age at least 18 years at the time of signing informed consent. for algeria only: age at least 19 years at the time of signing informed consent * type 2 diabetes subjects clinically diagnosed for at least 12 months prior to the day of screening (visit 1) * treated with basal insulin for at least 90 days prior to the day of screening (visit 1). the following basal insulin are allowed : insulin analogue once daily (od) neutral protamine hagedorn (nph) od or bid (twice daily) * treatment with metformin with or without one additional oad (oral antidiabetic drug) for at least 90 days prior to the day of screening (visit 1) metformin must be at a stable dose of at least 1500 mg daily or maximum tolerated dose for at least 60 days prior to screening (visit 1) one additional oad:sulphonylurea/glinides/ a-glucosidase inhibitors/dipeptidyl-peptidase-4 inhibitors/sodium glucose co-transporter 2 (sglt2) inhibitors (if applicable) * hba1c (glycosylated haemoglobin) 7.5%-10.0% (both inclusive) by central laboratory analysis at screening (visit 1) * able and willing to intake three main meals daily (breakfast, lunch and main evening meal) throughout the trial. definition of main meal as judged by the investigator exclusion criteria: * previous insulin intensification regimen for more than 14 days: premixed insulin thrice daily, basal-bolus regimen or continuous subcutaneous insulin infusion (csii). treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days * anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, systemic corticosteroids) * impaired liver function, defined as alanine aminotransferase (alt) equal to or above 2.5 times upper normal limit at screening (visit 1)
psychiatric problems in children and adolescents infected with hiv at birth

Conditions: HIV Infections; Mental Disorders

Summary: the purpose of this study is to determine whether hiv and anti-hiv drugs cause mental health problems or make mental health problems worse in children and adolescents who were infected with hiv at birth.

research has shown that hiv is able to penetrate the blood-brain barrier and may significantly affect the central nervous system (cns). although the effects of hiv on the cns are not fully understood, there is growing evidence that the effects are psychosocial in nature; hiv infected children experience higher rates of psychiatric symptoms and hospitalizations than their uninfected counterparts. confounding the hiv cns relationship is evidence suggesting that the cns effects of hiv may also be related to antiretroviral treatment. this study will examine the rates and severity of psychiatric symptoms in both hiv infected and uninfected children and adolescents. in addition, this study will determine the relationship between duration of antiretroviral treatment and psychiatric symptoms. no treatment will be given as part of this study. the study will last for 96 weeks and be divided into two parts. in part 1, hiv infected and uninfected participants and their caregivers will complete a series of measures and questionnaires regarding mental health, pain, and adherence to treatment. in part 2, all participants and their caregivers will complete a subset of the original measures at weeks 48 and 96. this follow-up part of the study will assess any long-term changes in psychiatric symptoms. in addition, a subset of hiv infected and uninfected participants and their caregivers will take part in psychiatric interviews at specified study sites. a portion of these interviews will be audio-taped.

Eligibility criteria:
inclusion criteria for hiv infected participants: * acquired hiv through mother-to-child transmission inclusion criteria for hiv uninfected participants: * hiv uninfected inclusion criteria for all participants: * living with same parent or primary caregiver for at least 12 months prior to study screening * willing and able to provide consent or assent exclusion criteria for hiv infected participants: * acquired hiv through adult high-risk behavior, blood transfusion, or abuse exclusion criteria for all participants: * iq of 69 or lower, for participants whose primary language is english. more information on this criterion can be found in the protocol.

Keywords: treatment experienced treatment naive psychopathology anti-retroviral agents child adolescent